Atopy
Conditions
Brief summary
This first-in-human study will evaluate the safety and tolerability of single doses of AK001 across a range of potentially active doses. Early signals of pharmacodynamic activity will also be evaluated.
Detailed description
AK001 is a monoclonal antibody which may be useful in the treatment of patients with severe allergic diseases.
Interventions
DRUGAK001
Given parenterally.
DRUGPlacebo
Sponsors
Allakos Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI between 18-30 * Determined to be in good health * Clinical laboratory values within limits of normal values * Normal 12-lead ECG * Stool sample negative for parasites * Non-smoker * Consumed an average of no more than 2 drinks per day within 6 months * Subjects of reproductive age must use a highly effective method of contraception * Positive skin test in certain cohorts * Elevated total eosinophil counts in certain cohorts
Exclusion criteria
* Clinically significant medical history conditions or laboratory values * Receipt of investigational drug, biologic or medical device within 30 days prior to Screening * New drug therapy within 1 week of study drug administration * Antihistamine use within 2 weeks prior to Screening * Consumption of alcohol within 48 hours of study drug administration * Positive urine drug test or cotinine test at Screening or Day -1 * History, within the last 2 years, of alcohol abuse, illicit drug use, or significant mental illness * Demonstration of veins unsuitable for repeated venipuncture or IV infusion * Recent treatment with alternative therapies which may confound clinical or laboratory assessments * Donation or loss of more than 500 mL of blood within 56 days prior to study drug administration * History of malignancy within last 5 years * History of severe allergic or anaphylactic reactions * Females who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of safety and tolerability of AK001 measured by number of subjects with adverse events and dose limiting toxicities (DLTs) respectively | Within 86 days |
Secondary
| Measure | Time frame |
|---|---|
| Immediate hypersensitivity skin testing | Within 28 days |
| Peripheral blood counts for eosinophils and basophils | Within 28 days |
| Serum eosinophilic cationic protein (ECP) and tryptase levels | Within 28 days |
| 24-hour urine measurement of histamine, N-methylhistamine, and 11-beta-prostaglandin F2 | Within 28 days |
Countries
United States
Outcome results
None listed